Worldwide, there have been more than 600 cases of BIA-ALCL, which develops when white blood cells called T-cells become abnormal. At least 16 women have died from the disease, including 9 in the U.S., FDA said.
The FDA, which first warned women about the cancer risk associated with textured breast implants in 2011, also announced Wednesday that for the first time that it is sending letters to primary care physicians and gynecologists urging them to learn about ALCL so they can better diagnose and treat women who may be at risk for the disease.
“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL,” said Dr. Ashar, director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health.
In a separate letter addressed to healthcare providers, the agency stated: “The FDA received reports indicating that patients with breast implants have an increased risk of developing this disease within the scar capsule adjacent to the implant.”
FDA’s warning comes 1 day before French health authorities were scheduled to discuss the safety of textured implants, which are used in cosmetic and reconstructive surgeries, and account for about 85% of breast implants on the French market. Most cases of ALCL have been linked to the textured implants, FDA said.
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Free Case Evaluation: Again, if you got cancer after receiving breast implants, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.